Randstad US CAPA Engineer in Andover, Massachusetts
salary:$26.66 - $39.32 per hour
date posted:Wednesday, October 13, 2021
industry:Professional, Scientific, and Technical Services
A CAPA Engineer is needed for a leader in electronics, healthcare, and lighting. This position is Remote. Candidate should have a Bachelor's degree in engineering, science or related field and Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001.
location: Remote, Remote
job type: Contract
salary: $26.66 - 39.32 per hour
work hours: 8am to 5pm
Facilitate Corrective and Preventive Action (CAPA) and nonconformance (NC) investigations from issue identification through the implementation of solution and effectiveness monitoring.
Project manage all aspects of CAPA and NC activity which includes gaining the commitment of cross-functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
Mentor CAPA teams with the implementation of appropriate root cause analysis techniques (e.g. Fishbone, Pride problem solving).
Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
Work effectively with all levels of management to ensure CAPA action plans can be supported and resources needed to implement the plan are available.
Independently produces and completes robust CAPA records (FTR).
Responsible for performing timely, detailed CAPA engineering tasks such as: assessing issue descriptions, reviewing CAPA data sources, conducting verification and validation activities for the action plan, assisting with root cause analysis and quality problem solving
Escalate issues that prevent CAPAs and NCs from being properly addressed
Bachelor's degree in engineering, science or related field.
Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001
At least 5+ years of experience in a medical device industry
Excellent people and communication skills, including the ability to express technical concepts in verbal and written form
Comfortable in a dynamic and evolving environment
Able to influence without authority
Analytical mindset. Focuses on the details while seeing the big picture.
Able to solve complex problems by bringing ideas into action.
strong project management, collaboration,?and organizational skills
strong aptitude for coordinating and assigning tasks
Enthusiastic, motivated and self driven
Quality Auditor Experience
Lean Six Sigma certification or working knowledge
Global project management experience. PMP a plus
Experience level: Experienced
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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